—#115199

Product

TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K934469
Affected lot / code info: Catalog Number: 909668 Lot Number Identification: 716710

Why it was recalled

Thru hole at the tip of the screw is undersized.

Root cause (FDA determination)

Reprocessing Controls

Action the firm took

Biomet sent an URGENT MEDICAL DEVICE RECALL letter dated January 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed locate and discontinue use of the affected product and return it to Biomet. recall notification was sent to all consignees on 1/4/2013. The action requires the immediate location and discontinued use of the product and its return to Biomet. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8a.m. to 5 p.m. For questions regarding this recall call 574-267-6639, ext 1676.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.

Timeline

Recall initiated: 2013-01-03
Posted by FDA: 2013-01-30
Terminated: 2013-08-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115199. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.